Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors

Inclusion Criteria

• Documented evidence of HER2 amplification/overexpression by local testing.
• Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic HER2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible.
• Subjects with a solid tumor malignancy for which HER2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved HER2-directed therapy.
• Measurable disease (at least one target lesion) per RECIST v1.1.
• Life expectancy > 12 weeks.
• ECOG 0-1.
• Adequate organ function.

Exclusion Criteria

• Symptomatic, untreated, or actively progressing central nervous system metastases.
• Prior CAR T cell or other genetically-modified T cell therapy.
• Impaired cardiac function or clinically significant cardiac disease.
• Symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs.
• Severe intercurrent infection.
• Pregnant or breastfeeding.
• Known HIV positivity.